An Observational Study of the Safety of Topiramate in Adults and Children With Epilepsy
The purpose of this observational study is to evaluate the safety of topiramate in adults and children with epilepsy (or seizures) who have not received or have not responded to treatment with previous antiepileptic medication.
|Study Design:||Time Perspective: Prospective|
|Official Title:||An Open Observational Safety Study During Administration of Topamac, as Monotherapy in Epileptic Patients With no Prior Treatment or Unsuccessfully Treated With Other Antiepileptic Drug|
- The primary outcome is efficacy. [ Time Frame: Visit 1-5 ] [ Designated as safety issue: Yes ]
- Tolerability [ Time Frame: Visit: 1-5 ] [ Designated as safety issue: No ]
- Safety of topiramate monotherapy [ Time Frame: Visit: 1-5 ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2005|
|Study Completion Date:||February 2007|
75 patients over the age of 2 years old with epilepsy.
Topiramate is a medication that is approved for the treatment of seizures. In accordance with international guidelines, studies are conducted after a drug is marketed to continue to evaluate and expand the knowledge regarding its safety. This is a multi-center, open-label observational safety study to collect information regarding the dosage, tolerability and effectiveness of topiramate in adults and children with epilepsy (or seizures). Patients who have not received previous treatment for epilepsy or for whom previous treatment was ineffective or intolerable will receive 6 months of treatment with topiramate. Topiramate will be given at low doses initially and gradually increased as needed for each patient to control seizure activity. Safety evaluations (incidence of adverse events and laboratory tests) and assessment of patient health status will be performed throughout the study. Effectiveness will be evaluated by recording the frequency of seizures occurring during the study. Patient and physician satisfaction with topiramate treatment will also be recorded. At the end of the study, the treating physician may continue treatment with topiramate in responding patients as appropriate. The study hypothesis is that topiramate will be effective in achieving and maintaining control of seizure activity and is well-tolerated. Observational study - No investigational drug administered.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00297323
|Study Director:||Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial||Janssen-Cilag Pharmaceutica S.A.C.I.|